Timing Frozen Embryo Transfer by Following Two Different Methods

NCT ID: NCT03156374

Last Updated: 2021-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This proof of concept study is designed to determine the practicality of using home ovulation tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in comparison to the standard ultrasound and serum monitoring currently conducted by many IVF clinics.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will evaluate the ability of home ovulation tests to accurately time Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition, women's likability and stress associated with timing a FET cycle using both methods will be evaluated by collecting qualitative data using standardised questionnaires.

The impact of psychological stress on FET outcome such as implantation rates and viability at first scan will be considered in order to gather information for the design of a larger clinical study and basic financial data will also be collected, in order to pilot a cost-effectiveness evaluation of the two FET timing methods.

A subset of volunteers will collect daily urine samples from day after embryo transfer until confirmation of pregnancy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fertility Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Parallel use of ovulation test and standard hospital monitoring, for agreement of methods
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ovulation test use

Use of both ovulation tests and standardised care

Group Type EXPERIMENTAL

Test use

Intervention Type DEVICE

Use of home ovulation test to predict ovulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Test use

Use of home ovulation test to predict ovulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women aged 24 to 45 years of age
* Undergoing no more than 5frozen embryo transfer
* Average cycle length between 26 and 35 days
* Willing to provide written informed consent to participate in the study and comply with all study procedures

Exclusion Criteria

* More than five IVF frozen embryo cycle
* Undergoing FET following cancer treatment
* Self-reported drug or alcohol dependency
* Self-reported history of depression, anxiety and panic attacks
Minimum Eligible Age

24 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SPD Development Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IVFAustralia - Bondi Junction

Bondi Junction, New South Wales, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROTOCOL-0897

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Predictive Value of Progesterone
NCT05876234 ACTIVE_NOT_RECRUITING
Progesterone-modified Natural Cycle for FET
NCT06644794 NOT_YET_RECRUITING PHASE3